Device recall
Z-0286-2016: CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY…
FDA device recall · Class II · Civco Medical Instruments Co. Inc.
Key facts
| Recall number (Z-number) | Z-0286-2016 |
|---|---|
| Recall event | 72378 |
| Product | CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. |
| Product code | ITX |
| Recalling firm | Civco Medical Instruments Co. Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2017 |
| 510(k) numbers | K093713 |
| FEI number | 1937223 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database